Adult Dosing

Hypertriglyceridemia (Lovaza, Omacor)

• 4 g/day PO divided daily to BID

Note:

• Put patients on an appropriate lipid-lowering diet before initiating therapy; continue this diet during treatment with omega-3 acid ethyl esters
• Administer with meals. Swallow the capsule whole; do not break open, crush, chew or dissolve the capsule

Omega-3 deficiency in patients with CVD

• 4 g PO qd

Pediatric Dosing

• Safety and effectiveness in pediatric patients have not been established

[Outline]

• Adult Dosing
• Pediatric Dosing

• As an adjunct to diet to reduce triglyceride (TG) levels in adult patients with severe (500 mg/dL) hypertriglyceridemia (Lovaza, Omacor)
• Dietary management of omega-3 deficiency associated with cardiovascular disease (Vascazen)

Note:

• The effect of omega-3 acid ethyl esters (Lovaza) on the risk for pancreatitis in patients with severe hypertriglyceridemia is unclear
• The effect of omega-3 acid ethyl esters (Lovaza) on cardiovascular mortality and morbidity in patients with severe hypertriglyceridemia is unclear

• Hypersensitivity to any of the ingredients of the product

• N/A

Renal Dose Adjustment

• Renal impairment: Dose adjustments not defined

Hepatic Dose Adjustment

• Hepatic impairment: Dose adjustments not defined

See Supplemental Patient Information

• Periodically monitor ALT and AST levels during therapy in patients with hepatic impairment as therapy may increase the ALT/AST levels
• Periodically monitor LDL-C and TG levels during therapy with omega-3 acid ethyl esters
• Use cautiously in patients with allergies to fish and/or shellfish as they may increase the risk of an allergic reaction to the drug
• Recurrent symptomatic atrial fibrillation or flutter may occur in patients with paroxysmal/persistent atrial fibrillation within the first 2-3 months after initiating therapy. Therapy should not be used for the treatment of AF or flutter

Caution: Use cautiously in

• Hypersensitivity to fish

Supplemental Patient Information

• Advise patients to swallow the capsule whole and instruct them not to break open, crush, dissolve or chew the capsule
• Inform patients that use of lipid-regulating agents does not reduce the importance of adhering to diet

Pregnancy Category:C (Lovaza, Omacor). Safety unknown (Vascazen)

Breastfeeding: Manufacturer advises caution.

• GI: Eructation, dyspepsia, taste perversion, constipation, GI disorder, vomiting
• METABOLIC: Elevated ALT and AST
• DERM: Pruritus, rash
• MUSC: Back pain
• HYPERSENSITIVITY: Anaphylactic reaction
• MISC: Infection, flu syndrome, Atrial flutter or fibrillation

Lovaza, Omacor

• Lipid-lowering agent; exact mechanism of action unknown, probably inhibits synthesis of triglycerides in the liver
• Metabolized in the liver
• Excretion: Unknown
• Half-life: Unknown

Vascazen

• Medical food; intends to restore and maintain healthy levels of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) in omega-3 deficient patients with CVD
• Metabolized in the liver
• Excretion: Unknown
• Half-life: Unknown

US Trade Name(s)

• Lovaza
• Omacor
• Vascazen

US Availability

Lovaza, Omacor, Vascazen

• CAPS: 1 g

Canadian Trade Name(s)

• N/A

Canadian Availability

• N/A

UK Trade Name(s)

• Omacor

UK Availability

Omacor

• CAPS: 1 g

Australian Trade Name(s)

• Omacor

Australian Availability

Omacor

• CAPS: 1 g

[Outline]

Cardiovascular

Lipid Lowering Agent

Fatty Acids

Pricing data from www.DrugStore.com in U.S.A.

• Lovaza 1 GM CAPS [Bottle] (GLAXO SMITH KLINE)
  120 gm = $190.99
  360 gm = $541.95

Warning: This pricing information is subject to change at the sole discretion of DS Pharmacy. For the most current and up-to-date pricing information, please visit drugstore.com.

• Lovaza 1000 MG Oral Capsule (GlaxoSmithKline LLC)
• Lovaza 1000 MG Oral Capsule (Physicians Total Care, Inc.)
• Lovaza 1000 MG Oral Capsule (Reliant Pharmaceuticals, Inc.)